Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The Myriad-LX light source is a high-intensity 300W Xenon illuminator with a touch screen and digital dimming controls. The source is fitted with a proprietary connector to ensure usage is reserved for the Myriad-LX Illumination Fiber.
Enforcement
- Recall Number
- Z-1840-2021
- Event ID
- 87882
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Nico Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- June 16, 2021
- Initiation Date
- April 30, 2021
- Classification Date
- June 9, 2021
- Termination Date
- February 5, 2024
- Address
- 250 E 96th St Ste 125, N/A, Indianapolis, IN, 46240-3872, United States
Description
Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The Myriad-LX light source is a high-intensity 300W Xenon illuminator with a touch screen and digital dimming controls. The source is fitted with a proprietary connector to ensure usage is reserved for the Myriad-LX Illumination Fiber.
(1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.
Serial Numbers 350-00194D 350-00355D 350-00356D 350-00357D 350-00376D through 350-00444D 350-00451D through 350-00460D 350-00463D through 350-00467D 350-004710 through 350-00475D
US Nationwide Distribution
80 units